DePuy Synthes has recalled a jaw implant that is supposed to gradually lengthen the jawbone. Instead, it can reverse direction and obstruct a patient’s airway. DePuy issued a Class I recall in August 2014 after receiving 15 reports of injury.
What You Can Do & How a Jaw Implant Injury Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting jaw implant induced injury cases in all 50 states.
If you or somebody you know was injured by the DePuy Synthes Craniomaxillofacial (CMF) Distraction System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
DePuy Jaw Implant
The Craniomaxillofacial (CMF) Distraction System is a jaw-lengthening implant that is manufactured by DePuy Synthes, a subsidiary of Johnson & Johnson. It is implanted on the jaw of infants who are born with birth defects of the mandible (lower jaw). It is also used in reconstructive surgery for children and adults who have had jaw injuries. In medical terminology, distraction means “gradual lengthening of bone.”
The jaw implant is also known as:
- External Mandibular Fixator
- External Mandibular Distractor
- Bone plate
Class I Recall for DePuy Jaw Implant
The U.S. Food and Drug Administration (FDA) announced a Class I recall for the DePuy Synthes CMF Distraction System on August 28, 2014. They received 15 reports of injury associated with the implants. The FDA warns:
“Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.”
What is the problem?
DePuy notified their customers of the recall in April 2014 with an Urgent Notice (PDF). According to the notice, the screws on the implant can reverse direction.
Jaw Implant Injuries
In most cases, frequent routine screening will detect the problem before it causes severe damage to the jaw. Most problems will be medically reversible and long-term injuries are not anticipated. Even so, DePuy is concerned about the following risks:
- Infants: Infants have the highest risk of injury because the device can obstruct the trachea and cut off the patient’s airway. This could lead to complications like respiratory arrest, choking, and death.
- Children and adults: Prolonged treatment is likely, but the problem is unlikely to cause serious injury for patients who can keep their airway open.
- All patients: May need to be treated with additional surgery to replace the implant.
Do I have a Jaw Implant Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting jaw implant induced injury cases in all 50 states. If you or somebody you know was injured by the DePuy Synthes Craniomaxillofacial (CMF) Distraction System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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